title: A feasibility study of intensive CAF as outpatient adjuvant therapy for stage II breast cancer in a cooperative group: CALGB 8443.
abstract: In preparation for a national Phase III study of dose and dose intensity in the treatment of node-positive, Stage II adenocarcinoma of the female breast, CALGB instituted a pilot study of intensive intravenous outpatient CAF (cyclophosphamide, Adriamycin, 5-fluorouracil) for four months. This study was designed to give full doses of drugs without dose reduction for hematologic toxicity. In order to evaluate the feasibility of physician and patient compliance with a potentially toxic therapy, a multi-institution pilot study was performed. This protocol demonstrated that a cooperative group could deliver toxic drug doses to outpatients with a median of 98% of cyclophosphamide, 97% of Adriamycin (doxorubicin), and 91% of 5-fluorouracil administered on schedule. Major side effects, as expected, were leukopenia, nausea, and vomiting. Disease-free survival is at least equivalent to that observed in previous studies.
authors.affiliation: Cancer and Leukemia Group B, Brookline, Massachusetts 02146.
authors.forename: D R
authors.initials: DR
authors.lastname: Budman
authors.forename: A H
authors.initials: AH
authors.lastname: Korzun
authors.forename: J
authors.initials: J
authors.lastname: Aisner
authors.forename: J
authors.initials: J
authors.lastname: Younger
authors.forename: R
authors.initials: R
authors.lastname: Silver
authors.forename: M
authors.initials: M
authors.lastname: Costanza
authors.forename: M A
authors.initials: MA
authors.lastname: Rice
authors.forename: W
authors.initials: W
authors.lastname: Wood
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007275:Injections, Intravenous; D008875:Middle Aged; D010045:Outpatients; D010349:Patient Compliance; D010865:Pilot Projects
chemical_list: D004317:Doxorubicin; D003520:Cyclophosphamide; D005472:Fluorouracil